Biosense‘s uCheck urinalysis system includes an iPhone app and a kit and uses Siemens’s and Bayer’s test strips, which have been cleared by the FDA. The company outlines several uses for urinalysis on its website such as pregnancy, urinary tract infection, hepatitis and malaria, to name a few. On the uChek website, the Mumbai India-based company presents the system as a “semi-automated” device. It acknowledges on the website that uChek is a medical device and adds that Biosense is an FDA registered facility.

In the letter the FDA explained that because the app “allows a mobile phone to analyze the dipsticks, the phone and device collectively function as an automated strip reader” triggering the need for 510(k) clearance.

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“…Therefore, any company intending to promote their device for use in analyzing, reading, and/or interpreting these dipsticks need to obtain clearance for the entire urinalysis test system (i.e., the strip reader and the test strips, as used together).”

The FDA has given the company 30 days to write a letter to justify why its app doesn’t require 510(k) clearance that other medical devices typically need. Despite the letter, the app is still available on iTunes, after it was released at the end of April. In another month, that could change. Watch this space.

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By Stephanie Baum

Stephanie Baum is the East Coast Innovation Reporter for MedCityNews.com. She enjoys covering healthcare startups across health IT, drug development and medical devices and innovations deployed to improve medical care. She graduated from Franklin & Marshall College in Pennsylvania and has worked across radio, print and video. She's written for The Christian Science Monitor, Dow Jones & Co. and United Business Media.Visit website | More posts by Author